Pharma firms allegedly blocking generic rivals from using drugs for tests

Canada’s competition watchdog said brand-name manufacturers are denying or delaying sales of their products

Pharma firms allegedly blocking generic rivals from using drugs for tests

The brand-name pharmaceutical industry has scored an advantage over their Canadian generic competitors from the recent US-Mexico-Canada Agreement (USMCA). Despite lobbying efforts from the Canadian Generic Pharmaceutical Association (CGPA), the new deal ultimately included provisions extending intellectual-property protections for biologic drugs by two years.

But the CGPA is waging another battle, this time with the help of Canada’s competition watchdog. According to a report published by The Star Phoenix, the Competition Bureau of Canada has filed court charges accusing brand firms of stymieing generic companies by blocking their access to their medicines.

According to court documents filed by the bureau that were obtained by the National Post, pharmaceutical companies have been “increasingly” denying or delaying sales of their medicines to generic manufacturers. Affidavits filed in court indicate that wholesalers, acting on orders from manufacturers, have clamped down on access to at least 20 drugs.

Generic firms need samples of drugs to comply with a Health Canada requirement to conduct tests proving that their cheaper versions produce similar effects in people as the original medication. Jim Keon, president of the CGPA, said the delays and denials started in the last few years, coinciding with a “patent cliff” that exposed numerous blockbuster drugs to generic competition.

The practice was originally applied for new specialty drugs that often require patients to be assisted or observed by health professionals and are dispensed only at manufacturer-authorized pharmacies. But Keon said that health rationale shouldn’t be expanded to deny access to generic companies. “I don’t think there’s any doubt this is an attempt to block competition, delay competition,” he said.

Denials or delays of the brand-name drugs could push back “the launch of generic drugs and prevent competition for some time,” the bureau said in an affidavit filed in the Federal Court of Canada. “Such practices can deprive consumers and the economy of the benefits of competition, including lower drug costs.”

Now it has come to light that the brand-name industry is facing a probe started quietly by the Competition Bureau in 2016. If the bureau finds that provisions in the Competition Act concerning restrictive trade practices were violated, it could levy fines of up to $15 million.

“There is no conclusion of wrongdoing at this time,” Competition Bureau Jayme Albert said earlier this month.

Meanwhile, the generics industry has called on Health Canada to introduce regulations to compel brand-name manufacturers to supply the drugs. Health Canada spokesman Geoffroy Legault-Thivierge has said the department is aware of the “ongoing challenges” for generics, is actively undertaking an investigation of the situation, and will implement any necessary follow-up measures.

 

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